Table 2.
Treatment-related AEs of any grade occurring in ≥ 10% of patients and grade 3 treatment-related AEs occurring in ≥ 1 patients in cohort 2
| Treatment-related AEsan (%) | Cohort 2 N = 25 |
|
|---|---|---|
| Any grade | Grade 3 | |
| Any | 25 (100.0) | 15 (60.0) |
| Hematologic | ||
| Decreased neutrophil count | 21 (84.0) | 12 (48.0) |
| Anemia | 5 (20.0) | 2 (8.0) |
| Decreased platelet count | 8 (32.0) | 2 (8.0) |
| Decreased WBC count | 4 (16.0) | 1 (4.0) |
| Febrile neutropenia | 1 (4.0) | 1 (4.0) |
| Nonhematologic | ||
| Nausea | 13 (52.0) | 1 (4.0) |
| Stomatitisb | 13 (52.0) | 5 (20.0) |
| Decreased appetite | 11 (44.0) | 2 (8.0) |
| Fatigue | 8 (32.0) | 2 (8.0) |
| Diarrhea | 8 (32.0) | 0 |
| Dysgeusia | 7 (28.0) | 0 |
| Constipation | 6 (24.0) | 0 |
| Vomiting | 6 (24.0) | 0 |
| Hiccups | 5 (20.0) | 0 |
| Malaise | 5 (20.0) | 0 |
| Palmar–plantar erythrodysesthesia syndrome | 4 (16.0) | 2 (8.0) |
| Alopecia | 4 (16.0) | 0 |
| Peripheral sensory neuropathy | 4 (16.0) | 0 |
| Hyperthyroidism | 4 (16.0) | 0 |
| Maculopapular rash or rash | 4 (16.0) | 2 (8.0) |
| Pyrexia | 3 (12.0) | 1 (4.0) |
| Decreased weight | 3 (12.0) | 1 (4.0) |
| Increased blood creatinine level | 3 (12.0) | 0 |
| Mucosal inflammationc | 3 (12.0) | 0 |
| Peripheral neuropathy | 3 (12.0) | 0 |
| Increased weight | 3 (12.0) | 0 |
| Hypophosphatemia | 1 (4.0) | 1 (4.0) |
| Polymyalgia rheumatica | 1 (4.0) | 1 (4.0) |
AE adverse event, WBC white blood cell
aAttribution of AEs to study treatment was determined by the investigator
bStomatitis refers to inflammation of the mouth and lips
cMucosal inflammation refers to inflammation of the mucous membranes